(157 days)
The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.
AccuBind™ Neo-Natal T4 Microplate EIA
The provided text is a 510(k) premarket notification approval letter for a medical device (AccuBind™ Neo-Natal T4 Microplate EIA) and its "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. This type of regulatory document confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not typically include the detailed scientific study data or performance metrics you've requested.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information (points 1-9) would typically be found in a separate submission document or a scientific publication related to the device's validation.
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.